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Fractyl Health, Inc. filings document regulatory, financial, governance and capital-structure disclosures for a clinical-stage metabolic therapeutics company developing Revita® and the Rejuva® gene therapy platform. Form 8-K reports furnish operating results, corporate presentations, REMAIN-1 clinical updates, Revita regulatory communications, Rejuva clinical-trial authorization for RJVA-001, and other Regulation FD disclosures.
The filing record also includes proxy materials for annual-meeting governance and equity-compensation matters, common stock and warrant disclosures, including Tranche A Common Stock Purchase Warrants, and Nasdaq continued-listing compliance notices. These documents describe the company’s public-company reporting, capital structure, stockholder voting matters and development-stage corporate disclosures.
Fractyl Health, Inc. reported randomized one-year data from the REMAIN-1 Midpoint Cohort evaluating its investigational Revita DMR System for weight maintenance after GLP-1 therapy discontinuation in adults with obesity. In the modified intention-to-treat population (N=45), a single Revita procedure reduced least-squares mean weight regain to 7.8% of body weight versus 13.0% with sham, a reduction of about 40% (n=29 Revita, 16 sham).
Among participants receiving complete duodenal ablation >14 cm, Revita patients had 4.8% weight regain versus 13.0% with sham, maintaining about 81% of GLP-1–induced weight loss at one year versus 48% with sham. In an optimized subgroup (complete ablation and ≥17.5% GLP-1 run-in loss), Revita maintained about 84% of weight loss versus 46% with sham (least-squares mean regain 4.1% vs 13.5%). The company notes these descriptive Midpoint results are not powered for formal inference but inform the pivotal design.
The weight-maintenance responder rate (≥5% total body weight loss vs pre-tirzepatide at one year), against an FDA performance goal >50%, was 73% in the Midpoint mITT population and 91% in the complete ablation group. No device- or procedure-related serious adverse events occurred; overall TEAE rates were 24% for Revita and 25% for sham, with one new diagnosis of type 2 diabetes in the sham arm and none with Revita. The REMAIN-1 Pivotal Cohort (≈315 patients) is fully randomized, with six-month topline data anticipated in early Q4 2026 and a potential FDA De Novo marketing application submission in late Q4 2026. Fractyl reports $63M of cash on hand at the end of Q1 2026, with runway into early 2027.
FRACTYL HEALTH, INC. director Ajay Royan made an open-market purchase of 23,000 shares of common stock on June 12, 2026 at a price of $0.852 per share. Following this trade, he directly holds 40,901 common shares.
Separately, the filing reports indirect holdings attributed to investment entities: 1,251,900 shares held by Mithril LP and 5,160,301 shares held by Mithril II LP. Royan may be deemed to have beneficial ownership through these entities but disclaims beneficial ownership except to the extent of any pecuniary interest.
Fractyl Health, Inc. held its 2026 Annual Meeting of Stockholders, where shareholders elected three Class II directors and ratified the company’s independent auditor. Ian Sheffield, Marc Elia, and Clive Meanwell were elected to three-year terms ending at the 2029 annual meeting.
Of 158,648,963 common shares outstanding as of April 17, 2026, 112,236,206 were represented at the meeting, reflecting approximately 70.7% of the voting power. Shareholders also approved the appointment of Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026.
FRACTYL HEALTH, INC. director William Bradley reported an open-market purchase of 68,493 shares of Common Stock at about $0.7348 per share, bringing his direct holdings to 84,622 shares. He also received a grant of stock options for 22,500 shares at a $0.7318 exercise price, expiring in 2036-06-09, which vest at the next annual stockholder meeting or the first anniversary of grant, subject to continued board service.
FRACTYL HEALTH, INC. director Samuel Conaway received a grant of stock options covering 22,500 shares of common stock at an exercise price of $0.7318 per share. These options were awarded as compensation for his board service and will vest in a single installment on the earlier of the next annual stockholder meeting or the first anniversary of the grant, subject to continued board service. Following this award, he holds 22,500 stock options directly.
FRACTYL HEALTH, INC. director Ajay Royan received a grant of stock options covering 22,500 shares of common stock at an exercise price of $0.7318 per share as compensation for service on the board.
The options vest in a single installment on the earlier of the next annual stockholder meeting or the first anniversary of the grant, subject to his continued service as a non-employee director, and expire on June 9, 2036. Following this award, Royan holds 22,500 stock options directly.
FRACTYL HEALTH, INC. director Christopher Charles Thompson received a grant of stock options covering 22,500 shares of common stock as compensation for his service on the board under the non-employee director compensation policy. The options have an exercise price of $0.7318 per share and expire on June 9, 2036. They vest in a single installment on the earlier of the next annual meeting of stockholders or the first anniversary of the grant, subject to his continued service as a non-employee director. Following this award, he holds 22,500 stock options directly.
FRACTYL HEALTH, INC. director Marc Elia received a stock option grant covering 22,500 shares of common stock as compensation for board service. The option has an exercise price of $0.7318 per share and expires on June 9, 2036.
The award will vest and become exercisable in a single installment on the earlier of the next annual stockholder meeting or the first anniversary of the grant, subject to Elia’s continued service as a non-employee director. After this grant, he holds 22,500 stock options directly.
FRACTYL HEALTH, INC. director Kelly Ann Barnes received a grant of stock options covering 22,500 shares of common stock as compensation for her board service. The options have an exercise price of $0.7318 per share and expire on June 9, 2036.
According to the terms, the award will vest in a single installment on the earlier of the next annual meeting of stockholders or the first anniversary of the grant, in each case subject to her continued service as a non-employee director. Following this grant, she holds 22,500 options directly.
FRACTYL HEALTH, INC. director Clive Meanwell received a grant of stock options as part of his non-employee director compensation. The award covers 22,500 options for common stock at an exercise price of $0.7318 per share, expiring on June 9, 2036.
The options vest in a single installment on the earlier of the next annual meeting of stockholders or the first anniversary of the grant date, assuming continued service on the board. Following this grant, Meanwell holds 22,500 stock options directly, with no open-market purchases or sales reported.